The following data is part of a premarket notification filed by Spineworks, Llc with the FDA for Spineworks Anterior Lumbar Device.
| Device ID | K133340 |
| 510k Number | K133340 |
| Device Name: | SPINEWORKS ANTERIOR LUMBAR DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEWORKS, LLC 815 IRIS LANE Vero Beach, FL 32963 |
| Contact | Robert Poggie, Phd |
| Correspondent | Robert Poggie, Phd SPINEWORKS, LLC 815 IRIS LANE Vero Beach, FL 32963 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-30 |
| Decision Date | 2014-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711A183060 | K133340 | 000 |
| M711A1426110 | K133340 | 000 |
| M711A123060 | K133340 | 000 |
| M711A1230110 | K133340 | 000 |
| M711A122660 | K133340 | 000 |
| M711A1226110 | K133340 | 000 |
| M711A103060 | K133340 | 000 |
| M711A1030110 | K133340 | 000 |
| M711A102660 | K133340 | 000 |
| M711A142660 | K133340 | 000 |
| M711A1430110 | K133340 | 000 |
| M711A1830110 | K133340 | 000 |
| M711A182660 | K133340 | 000 |
| M711A1826110 | K133340 | 000 |
| M711A163060 | K133340 | 000 |
| M711A1630110 | K133340 | 000 |
| M711A162660 | K133340 | 000 |
| M711A1626110 | K133340 | 000 |
| M711A143060 | K133340 | 000 |
| M711A1026110 | K133340 | 000 |